Multiple MyelomaPhase 2NCT05082675
Stem Cell Translpantation in Multiple Myeloma
A Phase 2 study testing HLA Matched allogeneic transplant in people with Multiple Myeloma, run by European Society for Blood and Marrow Transplantation at 24 sites in 11 countries.
Trial summary
The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- HLA Matched allogeneic transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 357 participants
- Where
- 24 sitesin 11 countries
- Study dates
- Sep 2001to Jan 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed Stage-II and III multiple myeloma (According to Durie and Salmon classification)
- Age under 70 years
- Life expectancy over 3 months
- Patients must be able to give informed consent
Who cannot join
- Serious concomitant medical disease which would limit life span or the ability to tolerate chemotherapy
- Severe cardiac failure (ejection fraction <40%)
- Impairment of renal function at diagnosis is not per se reason for exclusion but patients with severe impaired renal function (GFR <50 ml/min) after initial VAD (or VAD like) induction treatment are excluded
- Severe impairment of liver function (bilirubin >2 times upper limit of normal)
- Pregnant or lactating women
- Other major organ system dysfunction (GI, neurological, psychiatric dysfunction) that impairs tolerance of therapy or prolong hematological recovery
Trial locations and contacts
24 sites in 11 countries.
24 sites in 11 countries
Italy5 sites
Ospedale Ferrarotto
Catania, 95100
Ospedale di Careggi
Florence, 50134
University of Milano
Milan, 20133
Uni. Modena, Policlinico
Modena, 41100
IRCCS, Casa Sollievo della Sofferenza
San Giovanni Rotondo, 71013
Sweden4 sites
Sahlgrenska University Hospital
Gothenburg, 413 45
Huddinge University Hospital
Huddinge, 141 86
Study site
Stockholm
University Hospital
Uppsala, 75185
Finland3 sites
Helsinki University Central Hospital
Helsinki, 00029
Tampere University Hospital
Tampere, 33521
Turku University
Turku, 52 20521
Germany2 sites
University of Heidelberg
Heidelberg, 69120
University of Leipzig
Leipzig, 04103
About this study
Official title: A Phase-II Study Comparing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Following Autologous Transplantation to Autologous Transplantation Alone in Multiple Myeloma
The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.
Read the detailed description
This trial includes a natural (no available HLA-identical sibling donor) control arm. Patients with newly diagnosed multiple myeloma without a sibling are initially treated with conventional chemotherapy followed by conventional single or double autologous transplant (PBSCT). Data from this group is used as part of the control group.
Eligible patients with one or more sibling are offered to participate in the main trial arm. Those who decline are asked to consider taking part in the control group (autograft only).
Patients consenting to participate in the main study first receive the PBSCT, followed by the HLA-matched non-myeloablative allograft (matched for HLA -A, -B, -C, -DRB1).
All study patients receive four to six cycles of VAD (or alternative regimens specified in protocol) before PBSCT as first line treatment. Study entry starts at the time of starting conditioning for autologous transplantation. The search for an identical sibling donor begins as soon as the patient has consented to participate in the study.
The allograft is performed when the patient has restored their marrow function but no earlier than 3 months following PBSCT.
The aim is to demonstrate a difference in outcome (progression free survival, transplant related mortality, relapse rate, and survival).
- Conditions
- Multiple Myeloma
- Being tested
- HLA Matched allogeneic transplant
- Keywords
- myeloma, HLA-matched, autologous, allogeneic, transplant
- Medical subject headings
- Multiple Myeloma, Neoplasms, Plasma Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLA Matched allogeneic transplantProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| auto/RICallo treatment arm | Experimental | Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108) Receives: Procedure: HLA Matched allogeneic transplant |
| auto arm | Active comparator | patients without a matched sibling donor were allocated to the auto arm (n = 249). Single (n = 145) or tandem (n = 104) Receives: Procedure: HLA Matched allogeneic transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Progression free survival
Measured: 5 years
Secondary outcomes (4)
Transplant related mortality
Transplant related mortality
Measured: 5 years
Complete hematological and molecular remission rate
Complete hematological and molecular remission rate
Measured: 5 years
Relapse rate
Relapse rate
Measured: 5 years
Survival
Survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study startSep 2001
- Primary completionJan 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108) and patients without a matched sibling donor were allocated to the auto arm (n = 249)
- Masking
- None (open label)
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society for Blood and Marrow Transplantation
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Bo Björkstrand, MD, Study chair, Huddinge University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05082675
- Sponsor's protocol ID
- NMAM2000
- Status last verified
- Oct 2021
- First submitted
- 21 Sep 2021
- Last updated
- 11 Sep 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-II Study Comparing Non-Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation Following Autologous Transplantation to Autologous Transplantation Alone in Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05082675
- Acronym / sponsor ID
- NMAM2000
- Conditions
- Multiple Myeloma
- Keywords
- myeloma, HLA-matched, autologous, allogeneic, transplant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- European Society for Blood and Marrow TransplantationResearch network
- Study start
- Sep 2001
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 19 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether autologous transplantation (using the patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense) allogeneic transplantation (where the blood stem cells from a sibling donor are used for the transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.
Detailed description
This trial includes a natural (no available HLA-identical sibling donor) control arm. Patients with newly diagnosed multiple myeloma without a sibling are initially treated with conventional chemotherapy followed by conventional single or double autologous transplant (PBSCT). Data from this group is used as part of the control group.
Eligible patients with one or more sibling are offered to participate in the main trial arm. Those who decline are asked to consider taking part in the control group (autograft only).
Patients consenting to participate in the main study first receive the PBSCT, followed by the HLA-matched non-myeloablative allograft (matched for HLA -A, -B, -C, -DRB1).
All study patients receive four to six cycles of VAD (or alternative regimens specified in protocol) before PBSCT as first line treatment. Study entry starts at the time of starting conditioning for autologous transplantation. The search for an identical sibling donor begins as soon as the patient has consented to participate in the study.
The allograft is performed when the patient has restored their marrow function but no earlier than 3 months following PBSCT.
The aim is to demonstrate a difference in outcome (progression free survival, transplant related mortality, relapse rate, and survival).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108) and patients without a matched sibling donor were allocated to the auto arm (n = 249)
| Arm | Type | Receives |
|---|---|---|
| auto/RICallo treatment arm | Experimental | Procedure: HLA Matched allogeneic transplantPatients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108) |
| auto arm | Active comparator | Procedure: HLA Matched allogeneic transplantpatients without a matched sibling donor were allocated to the auto arm (n = 249). Single (n = 145) or tandem (n = 104) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly diagnosed Stage-II and III multiple myeloma (According to Durie and Salmon classification)
- Age under 70 years
- Life expectancy over 3 months
- Patients must be able to give informed consent
Key exclusion criteria (6 listed)
- Serious concomitant medical disease which would limit life span or the ability to tolerate chemotherapy
- Severe cardiac failure (ejection fraction <40%)
- Impairment of renal function at diagnosis is not per se reason for exclusion but patients with severe impaired renal function (GFR <50 ml/min) after initial VAD (or VAD like) induction treatment are excluded
- Severe impairment of liver function (bilirubin >2 times upper limit of normal)
- Pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLA Matched allogeneic transplant | Procedure or surgery | auto arm, auto/RICallo treatment arm |
Primary outcome
Progression free survival
Time frame: 5 years
Progression free survival
4 secondary outcomes
Transplant related mortality
Time frame: 5 years
Complete hematological and molecular remission rate
Time frame: 5 years
Relapse rate
Time frame: 5 years
Survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Sponsor's websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bo Björkstrand, MD study chair
Huddinge University Hospital
24 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLA Matched allogeneic transplant in people with Multiple Myeloma, run by European Society for Blood and Marrow Transplantation at 24 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in Italy, Sweden, Finland, Norway, Denmark and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.